Malaria, FalciparumPhase 1NCT06171113
A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
A Phase 1 study testing GSK4024484C in people with Malaria, Falciparum, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- GSK4024484C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Dec 2023to 16 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent.
- Participants who are considered healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac assessment.
- A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, or outside the normal reference range for the population being studied, may be included only if the Investigator considers, that the finding is unlikely to introduce additional risk factors for the participant and will not interfere with the study procedures or endpoints.
- ALT (Alanine transaminase) and AST (Aspartate transaminase) within the normal range at screening.
- Total bilirubin within the normal range unless the participant is known to have Gilbert's syndrome.
- Body weight ≥50kg, and BMI within the range 19 to 32 kilogram per square metre (kg/m^2) inclusive.
- Male participants and female participants who are not of child bearing potential.
- The participant is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Who cannot join
- History or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data in the opinion of the investigator.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- An average weekly alcohol intake of >14 units a week within 6 months prior to the study. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
- QTcF (Fridericia's formula) >450 msec based on average of triplicate ECGs. The QTcF is the QT interval corrected for heart rate according to QTcF.
- More than 100 ventricular ectopic complexes in 24 hrs by Holter screening or any other clinically significant Holter abnormalities determined by the investigator.
- Presence or history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.
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- Heart rate <40 or >100 beats per minute (bpm).
- Evidence of previous myocardial infarction or any clinically significant conduction abnormality such as (including but not specific to left complete bundle branch block, AV block [2nd degree or higher], WPW syndrome). Long standing RBBB is permitted.
- Past or intended use of over-the-counter or prescription medication, including herbal medications, CBD-based products, PPIs or H2 antagonists within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is the longest) prior to dosing. Other concomitant medication may be considered on a case by case basis by the investigator in consultation with the medical monitor. Paracetamol is permitted (capped at ≤2 grams/day).
- Participation in the study that would result in loss of blood or blood products in excess of 500 mL within a 56-day period.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Current enrolment or past participation (within the last 30 days before planned first dose in this study) in any other clinical study involving an investigational study intervention or any other type of medical research.
- Participants previously dosed in this study.
- Presence of HBsAg [or HBcAb] at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C RNA (ribonucleic acid) test result at screening or within 3 months prior to first dose of study intervention.
- Positive pre-study drug/alcohol screen.
- Positive HIV antibody test.
- Carbon monoxide levels indicative of smoking or more than 10 pack year history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Use of known recreational drugs or drugs of abuse.
- Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates participation in the study.
- A positive confirmation of COVID-19 infection according to local procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomised, Double Blind Placebo-controlled, First Time in Human Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Oral Doses and Food Effect of GSK4024484 in Healthy Adult Participants.
The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention.
- Conditions
- Malaria, Falciparum
- Being tested
- GSK4024484C, Placebo
- Keywords
- First time in human, Safety, Pharmacokinetics, GSK4024484, Healthy adults, Food effect, Single oral doses, Multiple oral doses
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK4024484CDrug
Doses administrated orally with 240 mL of water.
PlaceboDrug
Doses administrated orally with 240 mL of water.
| Study group | Role | What they receive |
|---|---|---|
| 6 mg single ascending dose (SAD) Group | Experimental | Participants receive a 6 mg single dose of GSK4024484, in a fasted state. Receives: Drug: GSK4024484C |
| 12 mg SAD Group | Experimental | Participants receive a 12 mg single dose of GSK4024484 in a fasted state. Receives: Drug: GSK4024484C |
| 24 mg SAD Group | Experimental | Participants receive a 24 mg single dose of GSK4024484 in a fasted state. Receives: Drug: GSK4024484C |
| 48 mg SAD Group | Experimental | Participants receive a 48 mg single dose of GSK4024484 in a fasted state. Receives: Drug: GSK4024484C |
| 96 mg SAD Group | Experimental | Participants receive a 96 mg single dose of GSK4024484 in a fasted state. Receives: Drug: GSK4024484C |
| 192 mg SAD Group | Experimental | Participants receive a 192 mg single dose of GSK4024484, in a fasted state. Receives: Drug: GSK4024484C |
| Food Effect Group | Experimental | Participants receive a single study dose of GSK4024484 in a fed state. Receives: Drug: GSK4024484C |
| 300 mg SAD Group | Experimental | Participants receive a 300 mg single dose of GSK4024484, in a fasted state. Receives: Drug: GSK4024484C |
| 400 mg SAD Group | Experimental | Participants receive a 400 mg single dose of GSK4024484, in a fasted state. Receives: Drug: GSK4024484C |
| Optional SAD Group | Experimental | Participants may be included in this group, to allow flexibility if the dose escalation needs modification or a dose level needs to be added or repeated. Receives: Drug: GSK4024484C |
| Placebo SAD Group | Placebo comparator | Participants receive placebo in a fed or fasted state. Receives: Drug: Placebo |
| 150 mg multiple ascending doses (MAD) Group | Experimental | Participants receive 150 mg per day of GSK4024484 during 3 subsequent days (450 mg total). Receives: Drug: GSK4024484C |
| 300 mg MAD Group | Experimental | Participants receive 300 mg per day of GSK4024484 during 3 subsequent days (900 mg total). Receives: Drug: GSK4024484C |
| Optional MAD Group | Experimental | Participants may be included in this group, to allow flexibility if the dose escalation needs modification or a dose level needs to be added or repeated. Receives: Drug: GSK4024484C |
| Placebo MAD Group | Placebo comparator | Participants receive placebo during 3 subsequent days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting serious adverse events (SAEs) after single ascending doses
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or an abnormal partner pregnancy outcome.
Measured: From the signing of the informed consent (Day -2) until the follow up contact (Day 38 +/- 3 days post dose)
Percentage of participants reporting SAEs by severity after single ascending doses
Mild SAE = a type of adverse event (AE) that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate SAE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe SAE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Measured: From the signing of the informed consent (Day -2) until the follow up contact (Day 38 +/- 3 days post dose)
Percentage of participants reporting SAEs after multiple ascending doses
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or an abnormal partner pregnancy outcome.
Measured: From the signing of the informed consent (Day -2) until the follow up contact (Day 40 +/- 3 days post dose)
Percentage of participants reporting SAEs by severity after multiple ascending doses
Mild SAE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate SAE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe SAE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Measured: From the signing of the informed consent (Day -2) until the follow up contact (Day 40 +/- 3 days post dose)
Percentage of participants reporting non-serious AEs after single ascending doses
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Measured: From study dose administration (Day 1) until the follow up contact (Day 38 +/- 3 days post dose)
Percentage of participants reporting non-serious AEs by severity after single ascending doses
Mild AE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate AE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe AE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Measured: From study dose administration (Day 1) until the follow up contact (Day 38 +/- 3 days post dose)
Percentage of participants reporting non-serious AEs after multiple ascending doses
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Measured: From first study dose administration (Day 1) until the follow up contact (Day 40 +/- 3 days post dose)
Percentage of participants reporting non-serious AEs by severity after multiple ascending doses
Mild AE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate AE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe AE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Measured: From first study dose administration (Day 1) until the follow up contact (Day 40 +/- 3 days post dose)
Secondary outcomes (19)
Part A: Area under the plasma drug concentration versus time curve from time zero (pre-dose) to last time of quantifiable concentration [AUC(0-t)] of GSK4024484C following single ascending doses in fasting conditions
Measured: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Area under the plasma drug concentration versus time curve from zero (pre-dose) extrapolated to infinite time [AUC(0-∞)] of GSK4024484C following single ascending doses in fasting conditions
Measured: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Maximum observed plasma drug concentration (Cmax) of GSK4024484C following single ascending doses in fasting conditions
Measured: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Time to maximum observed plasma drug concentration (Tmax) of GSK4024484C following single ascending doses in fasting conditions
Measured: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Apparent terminal half-life (t1/2) of GSK4024484C following single ascending doses in fasting conditions
Measured: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part B: AUC(0-t) of GSK4024484C following multiple ascending doses in fasting conditions
Measured: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: AUC(0-∞) of GSK4024484C following multiple ascending doses in fasting conditions
Measured: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: Cmax of GSK4024484C following multiple ascending doses in fasting conditions
Measured: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: Tmax of GSK4024484C following multiple ascending doses in fasting conditions
Measured: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: t1/2 of GSK4024484C following multiple ascending doses in fasting conditions
Measured: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: Area under the plasma drug concentration versus time curve from zero to time of trough plasma concentration [AUC(0-tau)] of GSK4024484C following multiple ascending doses in fasting conditions
Measured: Part B: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: Trough plasma concentration (Ctau) of GSK4024484C following multiple ascending doses in fasting conditions
Measured: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part A: AUC(0-t) of GSK4024484C following single ascending doses in fed conditions
Measured: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: AUC(0-∞) of GSK4024484C following single ascending doses in fed conditions
Measured: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Cmax of GSK4024484C following single ascending doses in fed conditions
Measured: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Tmax of GSK4024484C following single ascending doses in fed conditions
Measured: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: t1/2 of GSK4024484C following single ascending doses in fed conditions
Measured: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part B: Observed accumulation ratio (R) of GSK4024484 based on AUC(Ro) following multiple ascending doses
Measured: At Day 1 and at Day 3
Part B: Observed accumulation ratio (R) of GSK4024484 based on Cmax(RCmax) following multiple ascending doses
Measured: At Day 1 and at Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start11 Dec 2023
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171113
- Sponsor's protocol ID
- 218708
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Double Blind Placebo-controlled, First Time in Human Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Oral Doses and Food Effect of GSK4024484 in Healthy Adult Participants.
- ClinicalTrials.gov ID
- NCT06171113
- Acronym / sponsor ID
- 218708
- Conditions
- Malaria, Falciparum
- Keywords
- First time in human, Safety, Pharmacokinetics, GSK4024484, Healthy adults, Food effect, Single oral doses, Multiple oral doses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| 6 mg single ascending dose (SAD) Group | Experimental | Drug: GSK4024484CParticipants receive a 6 mg single dose of GSK4024484, in a fasted state. |
| 12 mg SAD Group | Experimental | Drug: GSK4024484CParticipants receive a 12 mg single dose of GSK4024484 in a fasted state. |
| 24 mg SAD Group | Experimental | Drug: GSK4024484CParticipants receive a 24 mg single dose of GSK4024484 in a fasted state. |
| 48 mg SAD Group | Experimental | Drug: GSK4024484CParticipants receive a 48 mg single dose of GSK4024484 in a fasted state. |
| 96 mg SAD Group | Experimental | Drug: GSK4024484CParticipants receive a 96 mg single dose of GSK4024484 in a fasted state. |
| 192 mg SAD Group | Experimental | Drug: GSK4024484CParticipants receive a 192 mg single dose of GSK4024484, in a fasted state. |
| Food Effect Group | Experimental | Drug: GSK4024484CParticipants receive a single study dose of GSK4024484 in a fed state. |
| 300 mg SAD Group | Experimental | Drug: GSK4024484CParticipants receive a 300 mg single dose of GSK4024484, in a fasted state. |
| 400 mg SAD Group | Experimental | Drug: GSK4024484CParticipants receive a 400 mg single dose of GSK4024484, in a fasted state. |
| Optional SAD Group | Experimental | Drug: GSK4024484CParticipants may be included in this group, to allow flexibility if the dose escalation needs modification or a dose level needs to be added or repeated. |
| Placebo SAD Group | Placebo comparator | Drug: PlaceboParticipants receive placebo in a fed or fasted state. |
| 150 mg multiple ascending doses (MAD) Group | Experimental | Drug: GSK4024484CParticipants receive 150 mg per day of GSK4024484 during 3 subsequent days (450 mg total). |
| 300 mg MAD Group | Experimental | Drug: GSK4024484CParticipants receive 300 mg per day of GSK4024484 during 3 subsequent days (900 mg total). |
| Optional MAD Group | Experimental | Drug: GSK4024484CParticipants may be included in this group, to allow flexibility if the dose escalation needs modification or a dose level needs to be added or repeated. |
| Placebo MAD Group | Placebo comparator | Drug: PlaceboParticipants receive placebo during 3 subsequent days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent.
- Participants who are considered healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac assessment.
- A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, or outside the normal reference range for the population being studied, may be included only if the Investigator considers, that the finding is unlikely to introduce additional risk factors for the participant and will not interfere with the study procedures or endpoints.
- ALT (Alanine transaminase) and AST (Aspartate transaminase) within the normal range at screening.
- Total bilirubin within the normal range unless the participant is known to have Gilbert's syndrome.
Key exclusion criteria (22 listed)
- History or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data in the opinion of the investigator.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- An average weekly alcohol intake of >14 units a week within 6 months prior to the study. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
- QTcF (Fridericia's formula) >450 msec based on average of triplicate ECGs. The QTcF is the QT interval corrected for heart rate according to QTcF.
- More than 100 ventricular ectopic complexes in 24 hrs by Holter screening or any other clinically significant Holter abnormalities determined by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK4024484CDoses administrated orally with 240 mL of water. | Drug | 12 mg SAD Group, 150 mg multiple ascending doses (MAD) Group, 192 mg SAD Group, 24 mg SAD Group, 300 mg MAD Group, 300 mg SAD Group, 400 mg SAD Group, 48 mg SAD Group, 6 mg single ascending dose (SAD) Group, 96 mg SAD Group, Food Effect Group, Optional MAD Group, Optional SAD Group |
| PlaceboDoses administrated orally with 240 mL of water. | Drug | Placebo MAD Group, Placebo SAD Group |
Primary outcome
Percentage of participants reporting serious adverse events (SAEs) after single ascending doses
Time frame: From the signing of the informed consent (Day -2) until the follow up contact (Day 38 +/- 3 days post dose)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or an abnormal partner pregnancy outcome.
Percentage of participants reporting SAEs by severity after single ascending doses
Time frame: From the signing of the informed consent (Day -2) until the follow up contact (Day 38 +/- 3 days post dose)
Mild SAE = a type of adverse event (AE) that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate SAE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe SAE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Percentage of participants reporting SAEs after multiple ascending doses
Time frame: From the signing of the informed consent (Day -2) until the follow up contact (Day 40 +/- 3 days post dose)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or an abnormal partner pregnancy outcome.
Percentage of participants reporting SAEs by severity after multiple ascending doses
Time frame: From the signing of the informed consent (Day -2) until the follow up contact (Day 40 +/- 3 days post dose)
Mild SAE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate SAE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe SAE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Percentage of participants reporting non-serious AEs after single ascending doses
Time frame: From study dose administration (Day 1) until the follow up contact (Day 38 +/- 3 days post dose)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Percentage of participants reporting non-serious AEs by severity after single ascending doses
Time frame: From study dose administration (Day 1) until the follow up contact (Day 38 +/- 3 days post dose)
Mild AE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate AE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe AE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Percentage of participants reporting non-serious AEs after multiple ascending doses
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 40 +/- 3 days post dose)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Percentage of participants reporting non-serious AEs by severity after multiple ascending doses
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 40 +/- 3 days post dose)
Mild AE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate AE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe AE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
19 secondary outcomes
Part A: Area under the plasma drug concentration versus time curve from time zero (pre-dose) to last time of quantifiable concentration [AUC(0-t)] of GSK4024484C following single ascending doses in fasting conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Area under the plasma drug concentration versus time curve from zero (pre-dose) extrapolated to infinite time [AUC(0-∞)] of GSK4024484C following single ascending doses in fasting conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Maximum observed plasma drug concentration (Cmax) of GSK4024484C following single ascending doses in fasting conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Time to maximum observed plasma drug concentration (Tmax) of GSK4024484C following single ascending doses in fasting conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Apparent terminal half-life (t1/2) of GSK4024484C following single ascending doses in fasting conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part B: AUC(0-t) of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: AUC(0-∞) of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: Cmax of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: Tmax of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: t1/2 of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: Area under the plasma drug concentration versus time curve from zero to time of trough plasma concentration [AUC(0-tau)] of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: Part B: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: Trough plasma concentration (Ctau) of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part A: AUC(0-t) of GSK4024484C following single ascending doses in fed conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: AUC(0-∞) of GSK4024484C following single ascending doses in fed conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Cmax of GSK4024484C following single ascending doses in fed conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Tmax of GSK4024484C following single ascending doses in fed conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: t1/2 of GSK4024484C following single ascending doses in fed conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part B: Observed accumulation ratio (R) of GSK4024484 based on AUC(Ro) following multiple ascending doses
Time frame: At Day 1 and at Day 3
Part B: Observed accumulation ratio (R) of GSK4024484 based on Cmax(RCmax) following multiple ascending doses
Time frame: At Day 1 and at Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK4024484C in people with Malaria, Falciparum, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants reporting serious adverse events (SAEs) after single ascending doses (time frame: From the signing of the informed consent (Day -2) until the follow up contact (Day 38 +/- 3 days post dose)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.